Thursday, February 22, 2024

The FDA’s First Draft Guidance on Psychedelics Paves the Way for Clinical Trials

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In an historic move, the United States Food and Drug Administration (FDA) has released a preliminary guide aimed at steering the investigation of psychedelic drugs for potential medical treatments.

The new FDA draft guidelines released today are primarily focused on assisting in the design of clinical trials for psychedelic substances in treating mental health and substance use disorders.

The announcement comes as the Psychedelic Science 2023 MAPS Conference is underway in Colorado. During the event on Wednesday, NFL quarterback Aaron Rodgers called for the legalization of psychedelics. The New York Jets quarterback who spent 18 seasons with the Green Bay Packers has been outspoken about his use of psychedelics.

“Is it not ironic that the things that actually expand your mind are illegal and the things that … dumb you down have been legal for centuries?” Rodgers said at the conference. “We’ve got to change that. We’ve got to change that. It’s through awareness and education.”

Aaron Rodgers
Aaron Rodgers used the psychedelic ayahuasca to help heal personal trauma | Courtesy Wikimedia Commons

Rodgers came out about his psychedelic use last year, which he said helped him to work through personal family issues. While the league didn’t penalize him for using psychedelics, many criticized the Super Bowl champion for his use of ayahuasca.

“I guarantee you all these bums who want to come after me online about my experience and stuff, they’ve never tried it,” he said. “They’re the perfect people for it. We need to get these people taking it.”

The therapeutic potential of psychedelics has caught the attention of the medical and scientific community in recent years, with possible applications for conditions such as depression, post-traumatic stress disorder, and substance abuse among others. However, constructing clinical studies to validate the safety and effectiveness of these compounds carries its unique set of challenges that require meticulous thought.

The FDA’s Tiffany Farchione, M.D., director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, said in a statement that psychedelic drugs show “initial promise as potential treatments for mood, anxiety, and substance use disorders.”

However, she cautions that these are still investigational products. “Sponsors evaluating the therapeutic potential of these drugs should consider their unique characteristics when designing clinical studies,” she said.

“By publishing this draft guidance, the FDA hopes to outline the challenges inherent in designing psychedelic drug development programs and provide information on how to address these challenges. The goal is to help researchers design studies that will yield interpretable results that will be capable of supporting future drug applications,” Farchione said.

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Psilocybin mushrooms Courtesy Mushroom Tao

The FDA guidance intends to counsel investigators on trial design and various factors during the development of psychedelic medications. In the scope of this draft, psychedelics are referred to as “classic psychedelics” such as psilocybin and lysergic acid diethylamide (LSD) which influence the brain’s serotonin system, as well as “entactogens” or “empathogens” like methylenedioxymethamphetamine (MDMA).

It outlines fundamental aspects throughout the drug development process, including trial conduct, data collection, participant safety, and new drug application prerequisites. Given the psychoactive properties of psychedelic drugs, which can trigger changes in mood and cognition, and induce hallucinations, there is a risk for abuse, demanding rigorous safety measures to prevent misuse throughout clinical development.

Furthermore, the draft specifies that for psychedelics classified as Schedule I controlled substances, all activities related to investigational studies under a New Drug Application must meet Drug Enforcement Administration regulatory standards.

While the standard of evidence required to confirm the effectiveness of psychedelic drugs aligns with that of all other drugs, unique elements may need consideration when structuring clinical trials to ensure they are adequately controlled.

The draft guidance additionally tackles the role of psychotherapy in psychedelic drug development, considerations for safety monitoring, and the significance of characterizing dose-response and the durability of any treatment effect.

The FDA has invited the public to offer their thoughts on the draft guidance within a 60-day window to ensure their considerations are included in the finalized version.

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